Targeted drug shows promise for rare Gene-Fueled cancers

NCT ID NCT06383884

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a drug called patritumab deruxtecan in adults with advanced solid tumors that have a rare genetic change called an NRG1 fusion. The drug aims to block signals that help these cancers grow. About 30 people will take part to see if the drug can shrink tumors and control the disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Apr 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Sign and date the tissue informed consent form (ICF) and the main ICF, prior to the start of any study-specific qualification procedures. * Male or female participants aged ≥18 years (follow local regulatory requirements if the legal age of consent for study participation is \>18 years old). * Histologically or cytologically documented locally advanced or metastatic solid tumor not amenable to curative surgery or radiation. * Documentation of NRG1 fusion detected from tumor tissue or blood sample, including but not limited to TruSightOncology-500, Guardant-360 or FoundationOne®CDx (F1CDx). * At least 1 measurable lesion confirmed by investigator as per RECIST v1.1 * At least 1 measurable lesion confirmed per RECIST v1.1 * Consented and willing to provide required tumor tissue of sufficient quantity (as defined in the Laboratory Manual) and of adequate tumor tissue content (as confirmed by hematoxylin and eosin \[H\&E\] staining). Required tumor tissue can be provided as either: 1. Pretreatment tumor biopsy from at least 1 lesion not previously irradiated and amenable to core biopsy OR 2. Archival tumor tissue collected from a biopsy performed within 3 months prior to signing of the tissue consent and since progression while on or after treatment with the most recent cancer therapy regimen. * Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at Screening. * Has adequate bone marrow reserve and organ function based on local laboratory data within 14 days prior to Cycle 1 Day 1. Platelet count: ≥100,000/mm\^3 or ≥100 × 10\^9/L (platelet transfusions are not allowed up to 14 days prior to Cycle 1 Day 1 to meet eligibility) 2. Hemoglobin: ≥9.0 g/dL (transfusion and/or growth factor support is allowed) 3. Absolute neutrophil count: ≥1500/mm\^3 or ≥1.5 × 10\^9/L 4. Serum creatinine (SCr) or creatinine clearance (CrCl): SCr ≤1.5 × upper limit of normal (ULN), OR CrCl ≥30 mL/min as calculated using the Cockcroft-Gault equation or measured CrCl 5. Aspartate aminotransferase/alanine aminotransferase: ≤3 × ULN (if liver metastases are present, ≤5 × ULN) 6. Total bilirubin: ≤1.5 × ULN if no liver metastases (\<3 × ULN in the presence of documented Gilbert's syndrome \[unconjugated hyperbilirubinemia\] or liver metastases) 7. Serum albumin: ≥2.5 g/dL 8. Prothrombin time (PT) or PT-International normalized ratio (INR) and activated partial thromboplastin time (aPTT)/PTT: ≤1.5 × ULN, except for subjects on coumarin-derivative anticoagulants or other similar anticoagulant therapy, who must have PT-INR within therapeutic range as deemed appropriate by the Investigator Exclusion Criteria: * Any history of interstitial lung disease (including pulmonary fibrosis or radiation pneumonitis) has current interstitial lung disease (ILD) or is suspected to have such disease by imaging during screening. * Clinically severe respiratory compromise (based on Investigator's assessment) resulting from intercurrent pulmonary illnesses including, but not limited to: 1. Any underlying pulmonary disorder (eg, pulmonary emboli within 3 months prior to the study enrollment, severe asthma, severe chronic obstructive pulmonary disease \[COPD\]), restrictive lung disease, pleural effusion); 2. Any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement (eg, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis); OR prior complete pneumonectomy. * Is receiving chronic systemic corticosteroids dosed at \>10 mg prednisone or equivalent anti-inflammatory or any form of immunosuppressive therapy prior to enrollment. Participants who require use of bronchodilators, inhaled or topical steroids, or local steroid injections may be included in the study. * Evidence of any leptomeningeal disease. * Evidence of clinically active spinal cord compression or brain metastases. * Inadequate washout period prior to Cycle 1 Day 1, defined as: 1. Whole brain radiation therapy \<14 days or stereotactic brain radiation therapy \<7 days; 2. Any cytotoxic chemotherapy, investigational agent or other anticancer drug(s) from a previous cancer treatment regimen or clinical study (other than EGFR TKI), \<14 days or 5 half-lives, whichever is longer; 3. Monoclonal antibodies, other than immune checkpoint inhibitors, such as bevacizumab (anti-VEGF) and cetuximab (anti-EGFR) \<28 days; 4. Immune checkpoint inhibitor therapy \<21 days; 5. Major surgery (excluding placement of vascular access) \<28 days; 6. Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation \<28 days or palliative radiation therapy \<14 days; or 7. Chloroquine or hydroxychloroquine \<14 days. * Prior treatment with an anti-human epidermal growth factor receptor 3 (HER3) antibody or single-agent topoisomerase I inhibitor. * Prior treatment with an antibody drug conjugate (ADC) that consists of any topoisomerase I inhibitor * Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0, Grade ≤1 or baseline. Participants with chronic Grade 2 toxicities may be eligible at the discretion of the Investigator. * Has history of other active malignancy within 3 years prior to enrollment, except: 1. Adequately treated non-melanoma skin cancer; 2. Superficial bladder tumors (Ta, Tis, T1); 3. Well-differentiated thyroid cancer 4. Adequately treated intraepithelial carcinoma of the cervix uteri; 5. Low risk non-metastatic prostate cancer (with Gleason score \<7, and following local treatment or ongoing active surveillance); 6. Any other curatively treated in situ disease. * Uncontrolled or significant cardiovascular disease prior to Cycle 1 Day 1 * Active hepatitis B and/or hepatitis C infection, such as those with serologic evidence of viral infection within 28 days of Cycle 1 Day 1.

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As listed by the trial registrant

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How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

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